BioScreen Testing offers a full range of services for the pharmaceutical industry. The pharmaceutical division provides stability studies, raw material testing, product release and validation services. All studies are conducted under the current Good Manufacturing Practices (cGMP) guidelines of the FDA. BioScreen is also registered with the Drug Enforcement Agency (DEA) to handle controlled substances and ISO 9002 certified. BioScreen has a national reputation for quality and integrity. The pharmaceutical division is staffed with industry experts experienced in pharmaceutical analysis and many different compounds.
BioScreen Testing is the largest industrial microbiology facility in the western United States. The company has 16 years of experience in microbiology testing for pharmaceutical, biotechnology and FDA regulated industries. All testing conforms to ISO 9002 and cGMP or GLP standards.
Common Tests Offered:
- Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests (Microbial Limits Test) USP and, BP/EP, JP, USP
- Microbiological Examination of Nonsterile Products: Tests For Specified Microorganism (Microbial Limits Test) USP and , BP/EP, JP USP
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Antimicrobial Effectiveness Tests, USP , EP, JP, PCPC (Formally CTFA), USP
- Preservative Systems Consulting
- Bacterial Endotoxin Tests, USP, BP/EP
- Gel Clot
- Kinetic
- Chromogenic
- Turbidimetric
- Sterility Test, BP/EP, USP
- Direct Immersion
- Bacteriostasis/Fungistasis
- Membrane Filtration
- Close (Steri Test)
- Open
- Particulate Matter USP , BP/EP
- Light Obscuration
- Microscopic
- Container Closure Study (Microbial Ingress)
- Microbial Reconstitution or In-Use Stability Studies
- Susceptibility Tests
- Minimum Bactericidal Concentration (MBC)
- Minimum Inhibitory Concentration (MIC)
- Log Reduction (Time Kill Study)
- Heterotrophic Plate Count
- Microorganism Identification
- MALDI-TOF
- Analytical Profile Index (API)